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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID(TM) MRSA
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BIOMERIEUX SA CHROMID(TM) MRSA Back to Search Results
Catalog Number 43841
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
On (b)(6) 2015 a customer called to report a false positive result when using chromid mrsa, ref.(b)(4), lot 1004215410.Customer stated results were (b)(6).Customer did not keep isolates for further investigation.Customer stated no patient results were affected but there was a delay of >24 hours in reporting results.
 
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Brand Name
CHROMID(TM) MRSA
Type of Device
CHROMID(TM) MRSA
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR  69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR   69280
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5213168
MDR Text Key30843585
Report Number3002769706-2015-00141
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial
Report Date 10/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2015
Device Catalogue Number43841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2015
Initial Date FDA Received11/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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